Kornimate/medical-research-clean huggingface dataset:
the study of effectiveness repetitive transcranial magnetic stimulation in bipolar depression

Conditions: Bipolar Disorder

Summary: the aim of this study is to investigate the effect of repetitive tms in reduction of depressive symptoms in patients with bipolar disorder. in a randomized, single blind clinical trials, 30 patients with bipolar disorder in atieh neuroscience center will be assigned to receive bilateral tms and unilateral tms, daily; for 20 sessions. the depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). qeeg apply before and after rtms in all subjects.


Eligibility criteria:
inclusion criteria: 1. outpatients male and female with the range of 18-65 years of age 2. the diagnosis of bipolar disorder according to dsm-iv-tr 3. completion of consent form 4. being under supervision of a psychiatrist, 5. having bdi\>14 6. being able to adhere to treatment schedule, 7. having stable symptoms as defined by not requiring a change in medication for at least 4 weeks . exclusion criteria: 1. the history of rtms treatment for any reason 2. intracranial implant and other ferromagnetic materials close to the head 3. cardiac pacemaker 4. drug pumps 5. the risk of seizure with any reasons 6. high intracranial pressure 7. the history of epilepsy or seizure in the first relatives 8. any metal in head 9. pregnancy 10. breastfeeding 11. high risk of suicide 12 having personality disorder in axis ii
treatment of opioid dependent patients with suboxone: acceptability & safety data from real life scenario (study p05603)

Conditions: Opioid-Related Disorders; Opiate Dependence; Drug Abuse

Summary: the aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with suboxone® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with suboxone is planned and indicated.

Eligibility criteria:
inclusion criteria: * both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. therapeutic indications and contraindications for suboxone® must be observed when selecting patients. exclusion criteria: * in accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

Keywords: suboxone subutex buprenorphine naloxone
a study to evaluate the safety, tolerability and efficacy of bmn 110 in subjects with mucopolysaccharidosis iva

Conditions: MPS IV A

Summary: this multicenter, open-label study is designed to assess safety, dose-response using pharmacokinetic (pk) and pharmacodynamic (pd) measures, and clinical efficacy of bmn 110 in subjects between 5 and 18 years of age, diagnosed with mucopolysaccharidosis iva (mps iva).


Eligibility criteria:
inclusion criteria: * documented history of reduced galns activity relative to the normal range of the laboratory performing the assay, or documented result of molecular genetic testing confirming diagnosis of mps iva. * willing and able to provide written, signed informed consent, or in the case of subjects under the age of 16 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures. * between 5 and 18 years of age, inclusive. * sexually active subjects must be willing to use an acceptable method of contraception while participating in the study. * females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. * willing to perform all study procedures as physically possible. exclusion criteria: * previous hematopoietic stem cell transplant (hsct). * has known hypersensitivity to bmn 110 or its excipients. * pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study. * use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. * concurrent disease or condition that would interfere with study participation or safety, including, but not limited to, symptomatic cervical spine instability. * any condition that, in the view of the principal investigator (pi), places the subject at high risk of poor treatment compliance or of not completing the study.

Keywords: mucopolysaccharidosis iv type a mps iv type a mucopolysaccharidosis iva mps iva morquio a syndrome lysosomal storage disorder lsd n-acetylgalactosamine-6-sulfatase n-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase galns enzyme replacement therapy ert
for patients with ischemic stroke, clinically study the effectiveness and safety of butylphthalide.

Conditions: Stroke; Cerebral Infarction; Brain Infarction; Brain Ischemia; Nervous System Diseases; Central Nervous System Diseases; Vascular Diseases

Summary: this is a prospective, open, single-arm, the real world of clinical trials. the researchers plan to recruit 300 eligible patients. the main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. correlation with its efficacy and adverse reactions.

ischemic stroke is one of the diseases that seriously threaten human health, with the characteristics of high incidence, high disability and high recurrence rate. patients will not only suffer from impaired physical function, but also mental symptoms, social function and other obstacles, which seriously affect the quality of life. butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. regarding the treatment of ischemic stroke with butylphthalide, there is still a lack of big data research based on real-world efficacy and safety; there is a lack of data on the pharmacokinetics of elderly patients and their correlation with adverse reactions. thus, it is estimated that 300 patients will be enrolled and given intravenous butylphthalide sodium chloride injection 25mg twice a day for 7-14 days, and then oral butylphthalide soft capsule 0.2g three times a day for 76-83 days. the patients will be collected for experiment before and after treatment. laboratory data, electrocardiogram, nihss, mrs, combined medication and adverse events, etc., to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke. in addition, a population pharmacokinetic model of butylphthalide in elderly patients was established for 50 of them.

Eligibility criteria:
inclusion criteria: * 1. female or male aged ≥ 18 years. * 2. acute ischemic stroke within 48 hours of onset * 3. examination to exclude intracranial hemorrhage * 4. provision of informed consent. exclusion criteria: * 1.head ct or mri suggests the presence of intracranial hemorrhagic disease * 2.patients with cerebral embolism or suspected cerebral embolism with severe atrioventricular block disease, atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate less than 50 beats per minute * 3.abnormal liver function (transaminase alt or ast exceeding the upper limit of normal), abnormal renal function (creatinine exceeding the upper limit of normal), or suffering from other serious systemic diseases, etc * 4.allergy to butylphthalide

Keywords: butylphthalide ischemic strokes
imaging and physiologic evaluation of coronary artery disease

Conditions: Ischemic Heart Disease; Atherosclerosis

Summary: to evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease (cad) undergoing invasive coronary angiography (ica), intravascular imaging, or invasive physiologic assessment.

the traditional standard method for evaluating coronary artery disease (cad) is invasive coronary angiography (ica). ica enables the assessment of anatomic severity of the epicardial artery and the severity of diameter stenosis can be closely associated with myocardial ischemia. however, there remains concern that anatomical severity is not always identical with functional significance. actually, even the patients showed positive non-invasive tests including treadmill test, stress echocardiography, coronary computed tomography angiography, or nuclear imaging, less than half of the patients showed significant stenosis on ica. therefore, the investigators need further investigation to overcome the limitations of ica. in this regard, intravascular imaging, such as intravascular ultrasound (ivus) and optical coherence tomography (oct), is a useful tool for assessing the anatomical severity in more detail. those imaging modalities produce cross-sectional images of cad and imaging modalities are allowing to assess lesion characteristics, plaque morphology, treatment planning, and optimization of the implanted stent. furthermore, imaging-guided percutaneous coronary intervention (pci) has been shown favorable outcomes, compared with angiography only-guided pci, especially in complex lesions. meanwhile, there has been an ample body of evidence that invasive coronary physiology assessment, such as fractional flow reserve (ffr), also can be useful for assessing the functional significance. therefore, the current guidelines have continuously recommended intracoronary imaging and invasive physiologic assessment for guiding the treatment of cad. the aim of the ip-cad (imaging and physiologic evaluation of coronary artery disease: a prospective registry study) is to evaluate the long-term clinical outcomes according to the imaging-guided or physiology-guided pci in real-world practice.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age * subjects who suspected ischemic heart disease and underwent ica. * subjects who were performed intravascular imaging or invasive physiologic assessment exclusion criteria: * subject with age \<18 years * pregnant women

Keywords: percutaneous coronary intervention intravascular imaging intravascular ultrasound optical coherence tomography fractional flow reserve
ptc drug sensitivity detection to guide postoperative adjuvant of colorectal cancer

Conditions: Colo-rectal Cancer

Summary: the research objectives is to compare vitro 3d drug sensitivity test results of micro tumor (ptc) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. the completion of this study will provide real-world data support for the clinical application of micro tumor (ptc) in vitro 3d drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.

the study is a multi agency prospective cohort study in china. the subjects were patients aged 18 \~ 75 years with colorectal cancer diagnosed by histopathology or cytology. they must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ecog physical condition score ≤ 2 points. and they must be voluntarily participate in and sign informed consent. the patients were randomly divided into ptc drug sensitivity test group and control group. the ptc drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3d drug sensitivity test results of micro tumor (ptc) in vitro. the control group made adjuvant chemotherapy strategy according to clinical experience. the primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was t-c \>- δ

Eligibility criteria:
inclusion criteria: 1. age 18 \~ 75 years old, regardless of gender 2. patients with colorectal cancer diagnosed by histopathology or cytology 3. colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy 4. having at least one assessable tumor focus 5. ecog physical condition score ≤ 2 points 6. voluntarily participate and sign informed consent exclusion criteria: 1. patients diagnosed with metastasis 2. patients who cannot obtain tumor samples 3. pregnant and lactating women 4. patients with poor compliance 5. patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment 6. patients with other malignant tumors 7. suffering from serious mental and nervous system diseases 8. the researchers believe that patients should not be selected for this study

Keywords: colon cancer rectal cancer adjuvant therapy ptc
gut microbiota dysbiosis in opioid use disorders: implications for clinical symptoms and relapse rate.

Conditions: Opioid Use; Opioid Use Disorder; Opioid Dependence

Summary: this study will aim to investigate the gut microbiota in egyptian patients with opioid use disorders and correlate microbiota bacterial abundance with clinical data.

addiction is defined as a chronic, relapsing disorder characterized by compulsive drug seeking and use despite adverse consequences. pathological substance use disorders represent a major public health crisis with limited effective treatment options. although the gut and brain are separate organs, they communicate with each other via trillions of intestinal bacteria that collectively make up one's gut microbiome. findings from both humans and animals support a critical role of gut microbes in regulating brain function, mood, and behavior. gut bacteria influence neural circuits that are notably affected in addiction-related behaviors. these include circuits involved in stress, reward, and motivation, with substance use influencing gut microbial abnormalities, suggesting significant gut-brain interactions in drug addiction. the investigator will discuss this role of gut microbiome in assuit university hospital to see how the pathogenesis can be altered of drug addiction.

Eligibility criteria:
inclusion criteria: 1. clinical and laboratory diagnosis of substance missuse. 2. must be encountering withdrawal symptoms for the first time. exclusion criteria: 1. an intelligence quotient (iq) below 70. 2. gastrointestinal diseases.

Keywords: gut microbiota . opioid use
a multicentre, single-arm, open-label safety study of lenalidomide plus dexamethasone in previously treated subjects with multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a multi-centre, single-arm treatment study combining lenalidomide plus high dose dexamethasone. subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles. subjects will be seen every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression is documented, study drug is discontinued for any reason or lenalidomide becomes commercially available for this indication. assessments of safety and quality of life are performed during the study.


Eligibility criteria:
inclusion criteria: * must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment. * subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to baseline. * females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence. exclusion criteria: * pregnant or lactating females
long-term follow-up of a cochlear implant with dexamethasone eluting electrode array

Conditions: Sensorineural Hearing Loss; Bilateral Hearing Loss

Summary: a long-term follow-up of cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.


Eligibility criteria:
inclusion criteria: * subjects who completed study obligations of the cltd5759 ci-dex study and enrolled at a site selected for participation. * subjects implanted with a ci632d or a ci632 cochlear implant under the cltd5759 (nct04750642). * willing and able to provide written informed consent. exclusion criteria: * unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the investigator. * additional disabilities that may affect the subject's participation or safety during the clinical investigation. * unable or unwilling to comply with all the requirements of the clinical investigation as determined by the investigator. * currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Keywords: cochlear implant dexamethasone bilateral hearing loss sensorineural hearing loss
evaluation of the resection of adenoma and colic adenocarcinoma by emr piecemeal or emr/esd hybrid technique

Conditions: Colorectal Adenoma; Intramucinous Adenocarcinoma

Summary: for tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique emr (mucosectomy dissection) /esd (submucosal dissection)


Eligibility criteria:
inclusion criteria: * age \> 18 years, * patient with colorectal adenoma or intramucinous adenocarcinoma exclusion criteria: * contraindication surgery
descriptive analysis of gut microbiome alterations in hyperoxaluric patients

Conditions: Oxalate, Primary Hyperoxaluria, Microbiome

Summary: to characterize the microbiome in 4 groups of subjects (primary hyperoxaluria type i (ph1), idiopathic caox stone, enteric hyperoxaluria (eh) and healthy participants) by comparing the number of species and diversity of the microbial populations and pathway for oxalate metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by gut bacteria.

kidney stones affect as much as 10% of the us population with the most common type of stones made of calcium oxalate. calcium and oxalate are present in the urine and can bind to each other, and form calcium oxalate kidney stones. oxalate is absorbed in the gut from the food that is eaten and is removed from the body through urination. gut bacteria is thought to play a role in decreasing oxalate absorption in the gut and its levels in the urine. with this research we hope to learn about differences in the bacteria that live in the gut of different groups of participants who are likely to form kidney stones, as well as healthy individuals. we will study healthy people with no history of kidney stones, people with a history of calcium oxalate (caox) kidney stones, people with a genetic disease called primary hyperoxaluria type1 (ph1) that increases their chances to form calcium oxalate kidney stones and, people with enteric hyperoxaluria (eh) a disease in which individuals have short bowels due to surgery which lead them to get calcium oxalate kidney stones. our research questions are: 1. how different is the gut bacteria between participants with the conditions that make them more likely to form kidney stones and healthy participants with no history of kidney stones? 2. is there any difference in the function of the individual bacteria, oxalobacter formigenes known to reduce oxalate, between healthy participants with no history kidney stones and participants with ph1?

Eligibility criteria:
inclusion criteria: * primary hyperoxaluria: patients diagnosed with type i ph by genetic testing and part of the rare kidney stone consortium (rksc) primary hyperoxaluria registry * enteric hyperoxaluria: patients with roux-en-y-gastric-bypass * idiopathic caox stone : history of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment * healthy participants with no history of kidney or bowel disease exclusion criteria: * history of kidney or liver transplant * history of antibiotics use within 6 months of recruitment
the use of dental pulp tissue as an autogenous graft for ridge augmentation

Conditions: Tooth Loss

Summary: the purpose of this study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. the effects on bone formation will be examined using a wide variety of assays.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status classification system asa 1 (a normal healthy patient) or asa 2 (a patient with mild systemic disease) * never smoker * patients with planned tooth extraction * intact extraction sockets * no medication or antibiotics intake for at least 6 months prior to the procedure * patients who gave their consent to participate in the study. exclusion criteria: * vulnerable subjects (children, pregnant and lactating women, patients with learning disabilities, and prisoners) * inability to obtain pulp tissue (for example, due to previous endodontic therapy, obliterated pulp canals)

Keywords: bone graft tooth extraction dental pulp
study of milnacipran for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia defined by 1990 american college of rheumatology (acr) criteria exclusion criteria: * psychiatric illness, * depression, * suicidal risk, * substance abuse, * pulmonary dysfunction, * renal impairment, * active cardiac disease, * liver disease, * autoimmune disease, * cancer, * inflammatory bowel disease

Keywords: fibromyalgia